Concussion Prevention in Female Soccer Athletes

Completed · Not applicable

Conditions studied: Concussion, Mild, Concussion, Brain

In brief

The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.

Key facts

Study ID

NCT03014492

Run by

Children's Hospital Medical Center, Cincinnati

People needed

72

Starts

2016-06-01

Expected to finish

2018-07-01

Last updated by the study team

2020-11-04

Who can join

Age: 14 and older, up to 19. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female
• Normal healthy volunteer
• Able to provide written consent
• Must be 14 years or older and a participant on a high school soccer team

You may not qualify if…

• Unable to provide written consent
• History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
• Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
• Glaucoma (Narrow Angle or Normal Tension)
• Hydrocephalus
• Recent penetrating brain trauma (within 6 months)
• Known carotid hypersensitivity
• Known increased intracranial pressure
• Central vein thrombosis
• Any known airway obstruction
• Any known seizure disorder

Where it is running

• Cincinanti Childrens Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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